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Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute on Aging (NIA)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00101387
First received: January 10, 2005
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of this study is to determine whether a form of electrical acupuncture, called percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older adults with chronic low back pain (LBP). This study will also determine the effects of general conditioning and aerobic exercise (GCAE) on chronic LBP.


Condition Intervention Phase
Low Back Pain
 Other: Lumbar PENS + General Conditioning and Aerobic Exercise
Other: Lumbar PENS
Other: Control Lumbar PENS
Other: Control PENS + exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Impact of PENS for 65+ Chronic Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Roland and Morris questionnaire [ Time Frame: Baseline, post-intervention, 6 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: September 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbar PENS + exercise
Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
 Other: Lumbar PENS + General Conditioning and Aerobic Exercise
As above
Active Comparator: Lumbar PENS
Lumbar PENS twice a week for 6 weeks
 Other: Lumbar PENS
As above
Placebo Comparator: Control PENS
Control lumbar PENS twice a week for 6 weeks
 Other: Control Lumbar PENS
Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
Active Comparator: Control PENS + exercise
Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise
 Other: Control PENS + exercise
as above

Detailed Description:

Each year, a significant number of elderly individuals experience at least one episode of LBP. When LBP becomes chronic, it can lead to functional and emotional impairment, increased health care utilization, and decreased quality of life. Standard treatment for LBP typically consists of non-opioid analgesics and physical therapy; however, analgesic-associated morbidity in older adults often limits their utility. This study will determine the efficacy of PENS treatment, a neuroanatomically guided form of electroacupuncture, and exercise in reducing pain in older adults with chronic LBP.

Participants will be randomly assigned to one of four treatment groups: PENS alone, PENS placebo, PENS plus GCAE, or PENS placebo plus GCAE. The treatments will be given twice weekly for 6 weeks. Pain intensity, physical function, health care utilization, and psychosocial function will be assessed with self-report and performance-based measures. These assessments will be conducted at study start, immediately after the last treatment session, and 6 months after study completion.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low back pain for at least 3 months
  • Able to walk without an assistive device (e.g., cane or walker)

Exclusion Criteria:

  • Serious underlying illness causing back pain
  • Nerve root compression
  • History of back surgery
  • Has pacemaker
  • Current use of blood thinners
  • Major psychiatric disorder
  • Chest pains or heart problems that interfere with daily activity
  • Fibromyalgia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101387

Sponsors and Collaborators
University of Pittsburgh
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Debra K. Weiner, MD Pain Evaluation and Treatment Institute
  More Information

No publications provided

Responsible Party: Christine Crawford, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00101387     History of Changes
Other Study ID Numbers: R01 AT000985-01A2, R01AT000985-01A2
Study First Received: January 10, 2005
Last Updated: February 17, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Aged
Acupuncture

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013